Hydrolyzed Pea Protein-Based Nutrient Composition

ABSTRACT

The present invention discloses a nutritional composition and method of using and making the nutritional composition. The nutritional composition is a hydrolyzed pea protein based nutrient composition for use in both enteral and oral feeding, and provides a non-allergenic diet for providing optimal nutrition to users. The nutritional composition is made from organic and plant-based ingredients. The nutritional composition has pea protein hydrolysates, phytochemical extracts, fatty acids, organic ingredients free of the top eight allergens and corn, and prebiotic fiber. The nutritional composition is provided in liquid form for enteral and/or oral feeding.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. patent application Ser. No.15/980,355 filed May 15, 2018 entitled Hydrolyzed Pea Protein-BasedNutrient Composition, the entire contents of which are incorporated byreference herein in their entirety for all purposes.

FIELD OF THE INVENTION

The present invention generally relates to nutrition and the healthcarefield. More specifically, the present invention relates to a natural andnon-allergenic hydrolyzed pea protein based nutrient composition for usein both enteral and oral feeding.

BACKGROUND OF THE INVENTION

Liquid nutrition supplements are well-known and have been readilyavailable in stores and for medical purposes for many years. Thesecompositions come in various flavors and can be can be consumed inaddition to a regular diet, as a replacement for meals in a day, or inlieu of food altogether. Initially, they were developed mostly for usewith medical supervision by the elderly, patients recovering fromillness, and others who need help putting on or retaining weight, butmore have recently been marketed for use by healthy adults.

In the medical field, these compositions are used to treat patients witha variety of ailments that have difficulty digesting foods and havedecreased nutrient intake caused by, for example: Gastroesophagealreflux, or rumination; malabsorption due to disorders such as shortbowel syndrome, jejunostomy, EOE (eosinophilic esophagitis), celiacdisease, cystic fibrosis, Crohn's Disease or disaccharidase deficiency;endocrine dysfunction resulting from conditions such as diabetesmellitus and proteinuria; increased energy requirements of diseases suchas bronchopulmonary dysplasia, cystic fibrosis, or hyperthyroidism; andincreased energy needs due to trauma, post-operative recovery,nutritional treatment before, during and after cancer treatment, andduring times of metabolic stress as seen with neurological disorderssuch as cerebral palsy and ALS. The above may be characterized generallyas Failure to Thrive (“FTT”). Approximately 3-5% of all childrenadmitted to tertiary care centers, and 1% of all children admitted toany hospital, are diagnosed with above ailments or the like.

Pediatric, and infant manufactured nutritional liquids and powderscomprising a targeted selection of nutritional ingredients are wellknown and widely available, some of which may provide a sole source ofnutrition, while others may provide a supplemental source. Some of thesenutritional liquids utilize pea protein as its main source of protein.

For example, WO 2013148685 to Neal et al describes a nutritionalcomposition including an intact pea protein concentrate as a soleprotein source in the nutritional composition because intact pea proteinimparts a number of important benefits to the nutritional compositionsincluding excellent texture, sweetness and a smooth and creamymouthfeel, as well as beneficial effects on glycemic control andresponse and glucose modulation.

Likewise, US 2003/0104033 to Hernendez et al teaches enteralformulations comprising 40-95 weight % of caseinate and 5-60 weight % ofa stabilizing protein, selected from the group of whey protein and oneor more vegetable proteins selected from the group of soy, corn, potato,rice and pea, the most preferred vegetable protein being soy protein.The document is concerned with the reduction of creaming in enteralformulae and is silent with respect to digestive properties ofhydrolyzed pea protein.

Another example is EP 1 972 346 (WO2007/063142) which discloses apea-based protein mixture comprising 50 weight % caseinate, 25 weight %whey proteins and 25 weight % pea proteins.

However, these examples disclose the use of intact proteins, do notcontemplate the use of pea protein hydrolysates together with otherorganic plant-based ingredients for patients with impairedgastrointestinal absorption and digestion, are generally whole-foodbased, nor are they free of common food allergens.

Indeed, food allergies in children are very common—almost 8% of the USchildren have some type of food allergy. Common allergens consist ofmilk (including whey, casein, and lactose), wheat, soybeans, eggs,peanuts, tree nuts, fish, shellfish, and corn. As nutrients arenecessary for proper growth and development, removing them from aregular diet leads to malnutrition issues. In particular, removal ofmilks and/or milk proteins, eggs, and soybeans from diet of childrenunder the growth ages presents a serious problem from the aspect of thedietetics. Currently, products in the markets utilize corn sweeteners,corn starches, synthetic corn derivatives and corn oils, many of whichare produced from genetically modified sources. In addition, theseproducts utilize the hydrolyzed protein of milk, whey or casein makingtheir products unavailable to those patients with galactosemia, who arelactose intolerant or have a milk allergy.

Furthermore, conventional peptide formulas do not contain these optimallevels of fatty acids, are often found to have an unfavorable mediumchain triglycerides (MCT) and long chain triglycerides (LCT) ratio, andno source of omega 3 fatty acids. Moreover, some of the products aremade of synthetic and artificial ingredients. These compositions provideunpleasant taste and odors, preventing them from being taken by patientsfor a prolonged period, even though they are theoretically free fromallergens.

In the light of above-mentioned problems, there is a need for a productthat addresses the issues faced by people and patients who rely upon aplant-based, vegan formula free of common allergens and syntheticingredients which are currently not found in the market. Further, thereis a need for a plant-based composition comprising phytonutrients,beneficial fats, and fibers, and are suitable for both oral and enteraladministration.

SUMMARY OF THE INVENTION

The present invention discloses a nutritional composition and method ofusing and making the nutritional composition. The nutritionalcomposition is a composition free of allergens for providing optimalnutrition to users. The nutritional composition is a plant-based, veganformula free of common allergens and synthetic ingredients. Thecomposition is based on a hydrolyzed pea protein composition for use inboth enteral and oral feeding

According to the present invention, the nutritional compositionconstitutes organic and plant-based ingredients. In an embodiment, thenutritional composition comprises at least one of a protein source, oneor more phytochemical extracts, one or more fatty acids, one or moreorganic ingredients free of common allergens (e.g., the top 8 allergens)and corn, and one or more prebiotic fibers. In one embodiment, theprotein source is pea protein hydrolysates. In one embodiment, thephytochemical extract is a blend of fruits, vegetables, herbs andspices. In another embodiment, the phytochemical extracts comprise oneor more combination of, blend of phytochemical extracts from fruits,vegetables, herbs, and spices, organic rosemary extract, potassiumcitrate, magnesium citrate and potassium chloride. In some embodiments,the blend of phytochemical extracts is sourced from a group of fruits,vegetables, herbs, and spices, comprising one or more concentrates ofbroccoli sprouts, camu camu, tomato, acai, turmeric, garlic, basil,oregano, cinnamon, elderberry, chokeberry, raspberry, spinach, kale,brussels sprouts, extracts of green arabica coffee bean, green tea,onion, apple, acerola, Japanese pagoda tree (quercetin), blackcurrant,blueberry, bilberry or any combination thereof.

In one embodiment, the fatty acids include organic medium chaintriglycerides (MCT) and a balanced blend of omega-6 and omega-3 fattyacids. In another embodiment, the fatty acids include organic sunflowerlecithin, organic flax seed oil and organic high linoleic sunflower oil.In one embodiment, the organic ingredient is a non-allergenicingredient. In another embodiment, the organic ingredient comprisesvanilla plant extract.

In one embodiment, the prebiotic fibers include organic inulin (fromagave). In another embodiment, the nutritional composition furtheroptionally comprises one or more vitamin and mineral blends, purifiedwater and sea salt.

In exemplary embodiments, the vitamin and mineral blend is selected froma group of dicalcium phosphate, potassium chloride, magnesium chloride,calcium carbonate, choline bitartrate, sodium ascorbate, trisodiumcitrate, potassium citrate, L-cysteine, Taurine, L-carnitine, inositol,L-tryptophan, DL-alpha-tocopheryl acetate, niacinamide, zinc oxide,ferric orthophosphate, calcium pantothenate, pyridoxine hydrochloride,copper sulfate, magnesium sulfate, riboflavin, thiamine hydrochloride,vitamin A palmitate, beta carotene, folic acid, biotin, chromiumpicolinate, phytonadione, sodium molybdate, sodium selenite, potassiumiodide, vitamin D2 and vitamin B12.

In some embodiments, the nutritional composition further optionallycomprises organic brown rice syrup solids, organic agave syrup, organicquinoa flour, organic vanilla flavor and organic milled chia.

In one embodiment, a method for producing the composition is disclosed.At one step, protein slurry is formed by adding and mixing hydrolyzedpea protein to water for ten minutes. At another step, a protein-fatslurry is formed by mixing fat to the protein slurry for five minutes.At another step, all dry ingredients are added to the protein-fat slurryand mixed for approximately five minutes. At another step, agave syrupis added to the mixture and mixed for approximately ten minutes. Atanother step, the composition is aseptically produced through amicrothermics processor. These steps may be performed at ambienttemperature and pressure.

Other objects, features and advantages of the present invention willbecome apparent from the following detailed description. It should beunderstood, however, that the detailed description and the specificexamples, while indicating specific embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF DRAWINGS

The embodiments herein will be better understood from the followingdetailed description with reference to the drawings, in which:

FIG. 1 is a graph illustrating high pressure liquid chromatography(HPLC) size analysis of pea protein in an embodiment of the presentinvention.

FIG. 2 is a graph illustrating peptide size and distribution comparisonof known whey protein products and pea protein product.

FIG. 3 is a flowchart illustrating a method preparing the nutritionalcomposition in an embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

The described embodiments are to be considered in all respects only asillustrative and not restrictive. The scope of the invention is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

Embodiments of the invention are discussed below with reference to theexamples. However, those skilled in the art will readily appreciate thatthe detailed description given herein with respect to these examples isfor explanatory purposes as the invention extends beyond these limitedembodiments. For example, it should be appreciated that those skilled inthe art will, in light of the teachings of the present invention,recognize a multiplicity of alternate and suitable approaches, dependingupon the needs of the particular application, to implement thefunctionality of any given detail described herein, beyond theparticular implementation choices in the following embodiments describedand shown. That is, there are numerous modifications and variations ofthe invention that are too numerous to be listed but that all fit withinthe scope of the invention. Also, singular words should be read asplural and vice versa and masculine as feminine and vice versa, whereappropriate, and alternative embodiments do not necessarily imply thatthe two are mutually exclusive

It is to be further understood that the present invention is not limitedto the particular methodology, compounds, materials, manufacturingtechniques, uses, and applications, described herein, as these may vary.It is also to be understood that the terminology used herein is used forthe purpose of describing particular embodiments only and is notintended to limit the scope of the present invention. It must be notedthat as used herein and in the appended claims, the singular forms “a,”“an,” and “the” include the plural reference unless the context clearlydictates otherwise. Thus, for example, a reference to “an element” is areference to one or more elements and includes equivalents thereof knownto those skilled in the art. Similarly, for another example, a referenceto “a step” or “a means” is a reference to one or more steps or meansand may include sub-steps and subservient means. All conjunctions usedare to be understood in the most inclusive sense possible. Thus, theword “or” should be understood as having the definition of a logical“or” rather than that of a logical “exclusive or” unless the contextclearly necessitates otherwise. Structures described herein are to beunderstood also to refer to functional equivalents of such structures.Language that may be construed to express approximation should be sounderstood unless the context clearly dictates otherwise.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art to which this invention belongs. Preferred methods,techniques, devices, and materials are described, although any methods,techniques, devices, or materials similar or equivalent to thosedescribed herein may be used in the practice or testing of the presentinvention.

The present invention discloses a nutritional composition and method ofusing said nutritional composition. According to the present invention,the nutritional composition is a non-allergic nutritional composition,which constitutes organic and plant-based ingredients. In oneembodiment, the nutritional composition comprises at least one of aprotein source, one or more phytochemical extracts, one or more fattyacids, one or more non-allergic organic ingredients, and one or moreprebiotic fibers. The organic ingredients are free of corn. Thenutritional composition further comprises one or more vitamin andmineral blends, purified water and sea salt. In another embodiment, thenutritional composition further optionally comprises organic brown ricesyrup solids, organic agave syrup, organic quinoa flour, organic vanillaflavor and organic milled chia. The nutritional composition is providedin liquid form for enteral and/or oral feeding. The present inventionalso provides an easily digestible organic plant-based peptide, which isa formulation of a vegan product free from the top eight allergens andcorn.

In one embodiment, the protein source is an organic hydrolyzed peaprotein. The concentration of organic hydrolyzed pea protein ranges from6 wt % to 9.2 wt %. In one embodiment, the organic hydrolyzed peaprotein constitutes 7 wt % of the total composition and is approximately100(%) of the total amount of protein in composition. In one embodiment,the organic hydrolyzed pea protein is an enzymatically digested organicintact pea protein.

In one embodiment, the hydrolyzed pea protein is 17% of the size of anintact protein. The hydrolyzed pea protein is produced by reduction froma 200-amino acid chain length down to a 34-amino acid chain length. Thisprocess produces a protein composition that is easily digestible. Thenutritional composition is a peptide-based composition serving the needsof patients with impaired gastrointestinal absorption and digestion. Theease of digestion of the proteins in pea are very high with a PDCAAS(Protein digestibility-corrected amino acid score) of 98% for theformulation and consequently delivers a full amino acid profile to thepatient or user. In addition, branched-chain amino acids in thecomposition are essential nutrients, where normally the body obtainsthis type of amino acid from food, especially meat, dairy products, andlegumes. In some embodiments, the branched-chain amino acids includeleucine, isoleucine, and valine:

Branched-chain amino acids stimulate the building of protein in muscleand possibly reduces muscle breakdown. Branched-chain amino acidsprevents faulty message transmission in the brain cells with advancedliver disease, mania, tardive dyskinesia, and other types of disease.Some pediatric nutritionists believe children would benefits from higherlevels of BCAA's (branched-chain amino acid) than currently recommended.Pea protein is a rich source of BCAA's.

According to the present invention, a 34 aa chain length was chosenbased on the influence of the peptide chain length of partial enzymichydrolysates of protein on nitrogen and amino acid absorption. It wasfound that nitrogen absorption was significantly slower from the higherchain length peptides. Similarly, longer amino acid residues were notabsorbed as well. The chain length of heterogeneous mixtures of peptidesaffects absorption of nitrogen and individual amino acid residues andsuggest that brush border hydrolysis of peptides limits absorption fromenzymic hydrolysates of protein. It was inferred that formulascontaining shorter length peptides are more readily accessible by thebody.

Referring to FIG. 1, a graph illustrating high pressure liquidchromatography (HPLC) size analysis of intact pea protein vs hydrolyzedpea protein in an embodiment of the present invention. Evaluation ofintact pea protein displayed a consistent distribution of protein sizeconfirming the control sample is comprised of long chain amino acidsthat do not vary in length. Conversely, intact pea protein that hasundergone enzymatic digestion resulted in varying peptide lengths as isevidenced by the molecular weight standard graph. These data concludethat hydrolysis decreased the average size of the peptide size ofexisting protein products. In addition, the resultant peptides showedthe majority falling into the molecular weight class of 34 amino acidchains. (Product¹ Source: “Peptide-Based Formulas: The Nutraceuticals ofEnteral Feeding?” E. Phillips et al., 2005 EPCN October:40-45”).Consequently, enzymatic hydrolysis of intact pea protein results in a“predigested” form of protein resulting in amino acids chains of 34amino acids, a relative 17% decrease in size as compared to the intactform of the protein.

Referring to FIG. 2, a graph illustrating peptide size and distributioncomparison of known whey protein products and pea protein product. Thegraph illustrated that the peptide size and distribution of the Peaprotein or enzymatically hydrolyzed pea protein is consistent andfavourable over the existing whey-based protein products examples 1, 2,3, and 4. (Product² Source: GlycosBio Food Science analysis, 2017).Consequently, pea protein hydrolysate compares favorably to hydrolysislevels seen in whey protein samples. The mean peptide chain forhydrolyzed pea protein in this instance was 34 amino acids long. Theresults were similar to the results of the hydrolyzed whey proteinsamples but provided a more consistent result. Studies have shown thatpea protein, and specifically peptides, have had positive outcomes inmuscle thickening, gastric emptying and heme transport, as compared tothe whey protein counterpart. Consistent production of peptide lengththrough the hydrolysis process has the potential to maintain thesepositive outcomes with consistently shorter peptide lengths beingassociated with faster nitrogen absorption, which is directly relatableto digestion and absorption of amino acid residues.

In one embodiment, the phytochemical extract is a blend of at leasttwenty-nine fruits, vegetables, herbs and spices. This naturalsupplement effects biological changes of oxidative and nitrosativestress markers (free radicals), nitric oxide levels, and cellularmetabolic activity. In another embodiment, the phytochemical extractsinclude organic rosemary extract, blend of phytochemical extracts fromfruits, vegetables, herbs, and spices, potassium citrate, magnesiumcitrate and potassium chloride. In some embodiments, the blend ofphytochemical extracts from fruits, vegetables, herbs, and spicescomprises any one or more of, concentrates of broccoli sprouts, camucamu, tomato, acai, turmeric, garlic, basil, oregano, cinnamon,elderberry, chokeberry, raspberry, spinach, kale, brussels sprouts,extracts of green arabica coffee bean, green tea, onion, apple, acerola,Japanese pagoda tree (quercetin), blackcurrant, blueberry, bilberry orany combination thereof. The chemical structure of selectedphytochemical, such as, glucosinolate, sulforaphane, curcumin,genistein, phenoxodiol (synthetic genistein analog), epigallocatechingallate (ECGC), lycopene and resveratrol are shown in Table 1.

TABLE 1

QUERCETIN

CATECHIN

CHLOROGENIC ACID

VITAMIN C

ANTHOCYANIN

GLUCOSINOLATES

LYCOPENE

ALLIIN

ALLICIN

BETA CAROTENE

In one embodiment, the maximum concentration of organic rosemary extractis 0.05 wt %. In another embodiment, the minimum concentration oforganic rosemary extract is 0.03 wt %. In one embodiment, the organicrosemary extract constitutes 0.03 wt % of the total composition. Therosemary-based extract is a natural oxidation-inhibiting product. In oneembodiment, the maximum concentration of blend of phytochemical extractsfrom fruits, vegetables, herbs, and spices is 0.04 wt %. In anotherembodiment, the minimum concentration of blend of phytochemical extractsfrom fruits, vegetables, herbs, and spices is 0.03 wt %. In oneembodiment, the blend of phytochemical extracts from fruits, vegetables,herbs, and spices constitute 0.04 wt % of the total composition. Theblend of phytochemical extracts is sourced from twenty-nine fruits,vegetables, herbs, and spices.

In one embodiment, the potassium citrate constitutes 0.021 wt %, whichis obtained from potassium source. In one embodiment, the magnesiumcitrate constitutes 0.01 wt %, which is obtained from magnesium source.In one embodiment, the potassium chloride constitutes 0.07 wt %., whichis obtained from potassium and chloride source.

In one embodiment, the fatty acid contains a balanced blend of essentialomega-6 such as sunflower and flax and omega-3 fatty acids such as ALA(alpha-linolenic acid) from flax, and easily digestible medium chaintriglycerides (MCT) from coconut oil. In one embodiment, the omega-6fatty acid is an essential fatty acid. Omega-3 has manyanti-inflammatory properties, and MCT is easily digestible, which actsas an immediate energy source via portal vein. In one embodiment, theMCT and long chain triglycerides (LCT) ratio is optimized to 40:60, andthe Omega 6 and Omega 3 ratio is formulated to 4:1. In anotherembodiment, the MCT and LCT ratio is optimized to 50:50 and the omega 6and omega 3 ratio is 3:1. In one embodiment, the maximum concentrationof organic medium chain triglycerides is 2.8 wt %. In anotherembodiment, the minimum concentration of organic medium chaintriglycerides is 2.3 wt %. In one embodiment, the concentration oforganic medium chain triglycerides is 2.74 wt %. In some embodiment, theMCT is a form of saturated fatty acid from coconut with medium-chainfats between 6-12 carbons.

In one embodiment, the composition comprises organic sunflower lecithin,organic flax seed oil, and organic high linoleic sunflower oil. In someembodiments, the concentration of organic sunflower lecithin is 0.1 wt%. Lecithin is a naturally occurring substance found in the membranes ofliving cells. Lecithin is extracted from sunflower seeds.

In one embodiment, the maximum concentration of organic flax seed oil is1.5 wt %. In another embodiment, the minimum concentration of organicflax seed oil is 1.1 wt %. In one embodiment, the concentration oforganic flax seed oil is 1.4 wt %. The organic flax seed oil is acolorless to yellowish oil obtained from the dried, ripened seeds of theflax plant.

In one embodiment, the maximum concentration of organic high linoleicsunflower oil is 3.5 wt %. In another embodiment, the minimumconcentration of organic high linoleic sunflower oil is 2.5 wt %. In oneembodiment, the concentration of organic high linoleic sunflower oil is3.00 wt %. The organic high linoleic sunflower oil is a variety ofsunflower oil containing nearly 70% polyunsaturated linoleic acid.

In one embodiment, the organic ingredients are non-allergenicingredients. In another embodiment, the organic ingredients includevanilla plant extract. The vanilla plant extract contains severalmedicinal properties, which could be useful for tackling severalailments. It is also a rich constituent of flavonoids, alkaloids,glycosides, carbohydrates and several other phytochemicals. The vanillaplant extract also contains both analgesic, antispasmodic, antioxidantand anti-inflammatory properties.

In one embodiment, the vitamin and mineral blends is selected from agroup of vitamins and minerals comprised of: dicalcium phosphate,potassium chloride, magnesium chloride, calcium carbonate, cholinebitartrate, sodium ascorbate, trisodium citrate, potassium citrate,L-cysteine, taurine, L-carnitine, inositol, L-tryptophan,DL-alpha-tocopheryl acetate, niacinamide, zinc oxide, ferricorthophosphate, calcium pantothenate, pyridoxine hydrochloride, coppersulfate, magnesium sulfate, riboflavin, thiamine hydrochloride, vitaminA palmitate, beta carotene, folic acid, biotin, chromium picolinate,phytonadione, sodium molybdate, sodium selenite, potassium iodide,vitamin D2 and vitamin B12.

In one embodiment, the maximum concentration of vitamin and mineralblend is 1.25 wt %. In another embodiment, the minimum concentration ofvitamin and mineral blend is 0.8 wt %. In one embodiment, theconcentration of vitamin and mineral blend is 1.22 wt %. The vitamin andmineral blend is a blend of vitamins, minerals and amino acids. In someembodiments, the concentration of the sea salt is 0.03 wt %. The seasalt is obtained from sodium and chloride source.

In one embodiment, the maximum concentration of purified water is 69.5wt %. In another embodiment, the minimum concentration of purified wateris 68 wt %. In one embodiment, the maximum concentration purified wateris 69.14 wt %, which is obtained from a water source.

In one embodiment, the prebiotic fibers include organic inulin (fromagave). In one embodiment, the maximum concentration of organic inulinis 1.2 wt %. In another embodiment, the minimum concentration of organicinulin is 1 wt %. In one embodiment, the concentration of organic inulinis 1.20 wt %. The organic Agave inulin is a highly soluble dietary fiber(inulin-type fructan) that provides numerous health benefits. Inulinserves as a “fertilizer” to sustain beneficial bifidobacteria in thelarge intestine.

The prebiotic fiber is clinically proven to be easy to digest (low gaspotential) and promote the growth of good bacteria in the gut such asbifidobacteria. Further, Fecal Actinobacteria and Bifidobacterium wereenriched 3- and 4-fold after ingestion of agave inulin, a long chainfructo-oligosaccharide (FOS), and desulfovibrio were depleted 40% withagave inulin. Agave inulin tended to reduce fecal 4-methyphenol and pH.A positive association between intakes of agave inulin andBifidobacterium is briefly described herein. Total dietary fiber fromagave inulin was positively associated with fecal butyrate and tended tobe positively associated with bifidobacterium and was negativelycorrelated with desulfovibrio abundance. FOS could fosterBifidobacterium colony growth, which could also serve as food for lessdesirable strains of bacteria. Chicory inulin, a source of prebioticfiber, encourages the growth of klebsiella, which causes problems withintestinal permeability. It also feeds E. coli and many Clostridiumspecies, which are inharmonious with gut-friendly bacteria.

In one embodiment, the nutritional composition further optionallycomprises organic brown rice syrup solids and organic agave syrup. Inone embodiment, the maximum concentration of organic brown rice syrupsolid is 12 wt %. In another embodiment, the minimum concentration oforganic brown rice syrup solid is 6.5 wt %. In one embodiment, theconcentration of organic brown rice syrup solid is 10 wt %.

In one embodiment, the maximum concentration of organic agave syrup is6.5 wt %. In another embodiment, the minimum concentration of organicagave syrup is 2.25 wt %. In yet one embodiment, the concentration oforganic agave syrup is 6 wt %. The organic agave syrup is a naturalalternative to refined sugars and artificial sweeteners, extracted fromthe agave plant.

In another embodiment, the nutritional composition further optionallycomprises organic quinoa flour in the concentration of 0.02 wt %. Theorganic quinoa flour is a ground powder from the seeds of Salviahispanica, commonly known as chia, a species of flowering plant in themint family, lamiaceae, native to central and southern Mexico andGuatemala. In yet another embodiment, the nutritional compositionfurther optionally comprises organic vanilla flavor in the concentrationof 1.1 wt %, which is derived from orchid seed pods of the genusVanilla. In another embodiment, the nutritional composition furtheroptionally comprises organic milled chia in the concentration of 0.01 wt%.

The composition should contain a therapeutically effective amount ofeach ingredients, and also those described in Table 2. The ingredientsof the therapeutic composition according to the present invention aresummarized in Table 2 below with respect to a description thereof, theactive ingredients therein, percentages by weight range for each activeingredient, and the benefits thereof.

TABLE 2 Minimum Maximum Range Current Range Ingredient % % % DescriptionOrganic 2.25 6.00 6.5 A natural alternative to Agave refined sugars andSyrup artificial sweeteners from the agave plant Organic 6.5 10.00 12 Anatural alternative to Brown refined sugars and Rice artificialsweeteners from Syrup the agave plant. Solids (20 de) Organic 1.1 1.401.5 A colorless to yellowish Flax oil obtained from the Seed dried,ripened seeds of Oil the flax plant Organic 2.5 3.00 3.5 Variety ofsunflower oil High containing nearly 70 Linoleic percent polyunsaturatedSunflower linoleic acid Oil Organic 6 7.00 9.2 Enzymatically digestedHydrolyzed organic intact pea Pea protein Protein Organic 1 1.20 1.2Agave inulin is a highly Inulin soluble dietary fiber (inulin-typefructan). Inulin serves as a “fertilizer” to sustain beneficialBifidobacteria in the large intestine. Organic 2.3 2.74 2.8 A form ofsaturated fatty Medium acid from coconut with Chain medium-chain fatsthat Triglyc- have between 6-12 erides carbons (Derived from Coconut)Organic 0.01 0.01 0.01 A ground powder from the Milled seeds of Salviahispanica, Chia commonly known as chia, is a species of flowering plantin the mint family, Lamiaceae, native to central and southern Mexico andGuatemala. Organic 0.02 0.03 0.02 A ground powder from the Quinoa seedsof Salvia hispanica, Flour commonly known as chia, is a species offlowering plant in the mint family, Lamiaceae, native to central andsouthern Mexico and Guatemala. Organic 0.03 0.03 0.05 A naturaloxidation- Rosemary inhibiting product Extract Organic 0.1 0.10 0.1 Anaturally occurring Sunflower substance found in the Lecithin membranesof living cells. Lecithin is extracted from sunflower seeds. Organic 1.11.10 1.1 Flavor derived from Vanilla orchid seed pods of the Flavorgenus Vanilla Potassium 0.21 0.22 0.21 Source of Potassium CitratePurified 68 69.14 69.5 Source of water Water Sea 0.03 0.03 0.03 Sourceof Sodium Salt and Chloride Blend 0.03 0.04 0.04 blend of phytochemicalof extracts from 29 fruits, phytochem- vegetables, herbs, and icalspices. extracts from fruits, vegetables, herbs, and spices Vitamin 0.81.22 1.25 Source of 25 vitamins, and minerals and amino Mineral acidsBlend Magnesium 0.1 0.10 0.1 Source of Magnesium Citrate Potassium 0.070.07 0.07 Source of Potassium Chloride and Chloride

In an embodiment, the therapeutic effects of the nutrition compositionare numerous. The nutrition composition comprises agave syrup. Itcontains a higher level of fructose than high fructose corn syrup. Animportant difference is that fructose is up to twice as sweet assucrose, and sweeter than high fructose corn syrup. Unlike table sugaror HFCS, fructose does not cause a rapid rise and subsequent large fallin blood glucose levels, which means it has a low glycemic load orglycemic index (GI). The glycemic index is a value assigned to foodsbased on how slowly or how quickly those foods cause increases in bloodglucose levels. The blood glucose levels above normal are toxic and cancause blindness, kidney failure, or increase cardiovascular risk. Foodcomponents that are low on the glycemic index (GI) scale tend to releaseglucose slowly and steadily. Food components that are high on theglycemic index release glucose rapidly. Low GI foods tend to fosterweight loss, while foods high on the GI scale help with energy recoveryafter exercise, or to offset hypo- (or insufficient) glycemia. For anaverage diet, there are no health problems associated with fructoseexcept for some individuals, who may be fructose intolerant.

Fructose was given GRAS status in 1983 and was reconfirmed in 1996 aftera study of the available clinical trials on the effects of fructoseconsumption. Fructose has a low glycemic index, which can be used tohelp control blood glucose levels in concern with a total diet plan.Agave syrup is not processed in the same manner as corn syrup. Agavenaturally contains inulin, a long chain fructose molecule. Fructose,sometimes known as fruit sugar, exists naturally in fruits and honey asa single unit of fructose. It exists naturally in inulin as a long chainof fructose molecules linked together, similar to the glucose chains instarch. The bonds in inulin can be broken to make free fructose. When aperson eats a food containing inulin, the body's enzymes do not breakdown the inulin. Instead, the inulin is consumed by bacteria in theintestine. The bacteria that consume the inulin tend to be thebeneficial bacteria, the same types found in yogurts and variousprobiotic foods. As the inulin feeds these beneficial organisms,allowing them to outcompete the detrimental intestinal organisms, inulinis labeled a prebiotic and has many health benefits. While fructosecould be made by hydrolyzing or breaking the bonds of inulin, it couldalso be made by using an isomerase enzyme to change glucose intofructose.

In one embodiment, the composition comprising the organic brown ricesyrup solid (BRSS) is a natural alternative to refined sugars andartificial sweeteners from the agave plant. Unlike refined table sugar,which causes the body to work harder to absorb the sucrose, brown ricesyrup is able to provide body with fiber, as well as 3% of a user'srecommended daily intake of sodium and potassium. As the rice syrupsolids are boiled and the liquid are removed, the result is a complex ofsimple sugars. This facilitates slower absorption of the sugars in ricesyrup by the digestive system. This is a huge advantage because in thecase of regular table sugar, there is rapid swell in blood sugar levelwith buildup of excess fat with time. The slower absorption of thesugars also allows the user or patient to maintain their energy andprevents the negative effects of sugar including fatigue, irritabilityand the desire for more sugar.

All these properties indicate that BRSS also have a low glycemic index.The use of the natural sweetening ability of BRSS is unique in the spaceof medical grade sole source nutrition. BRSS is a far superior optionthan maltodextrin, commonly used as a carbohydrate in comparableproducts. Maltodextrin is used as a thickener, filler or preservative inmany processed foods. It is an artificially produced white powder thatcan be enzymatically derived from any starch but is commonly made fromcorn, rice, potato starch or wheat. Maltodextrin is also used incarbohydrate supplements that are marketed to athletes and bodybuildersas a way to boost their energy levels. However, consuming maltodextrinleads to spiked blood sugar, suppresses the growth of probiotics,toxically affect several bodily organs and systems, and causes allergicreactions or side effects because it is derived from corn.

In one embodiment, the organic flax seed oil is derived from theextremely nutritious and disease-preventing flax seed. The flax seed oilhas a high concentration of healthy omega-3s as fatty acids associatedwith healthier brains and hearts, better moods, decreased inflammation,and healthier skin and hair. Flax seed oil contains 50% to 60% ofomega-3 fatty acids in the form of alpha-linolenic acid (ALA). Flax seedis the richest plant source of the omega(ω)-3 fatty acid, i.e.α-linolenic acid (ALA). Flax seed oil is low in saturated fatty acids(9%), moderate in monosaturated fatty acids (18%), and rich inpolyunsaturated fatty acid (73%). Of all lipids in flaxseed oil,α-linolenic acid is the major fatty acid ranging from 39% to 60.42%followed by oleic, linoleic, palmitic and stearic acids, which providesan excellent omega (ω)-6: omega (ω)-3 fatty acid ratio of approximately0.3:1. Flax seed oil is naturally high in anti-oxidants like tocopherolsand beta-carotene. Flax seed oil provides basic nutrition as well asvarious health benefits in reducing cancer and cardiovascular diseases,lowering LDL-cholesterol and vasodilatory functions. Therefore, flaxseed oil could be considered as a functional food. Flax seed oil isemerging as an important functional food ingredient, because of its richcontents of α-linolenic acid (ALA, omega-3 fatty acid), lignans, andfiber. Flax seed oil, fibers and flax lignans have potential healthbenefits such as, in reduction of cardiovascular disease,atherosclerosis, diabetes, cancer, arthritis, osteoporosis, autoimmuneand neurological disorders.

The organic high linoleic sunflower oil comprises essential omega-6,impressive fatty acid content, which includes palmitic acid, stearicacid, oleic acid, and linoleic acid. The combination of fatty acids inthe body are extremely important to maintain various elements of humanhealth, and sunflower oil could help to maintain the balance. Thebalance of fatty acids found in sunflower oil, including a substantialamount of linoleic acid (an omega-6 fatty acid) is optimal for patients.Finding a healthy balance between HDL or good cholesterol (omega-3s) andLDL or bad cholesterol is very important to the health of patients.Furthermore, sunflower oil does not contain any saturated fats, whichmeans that it could actually reduce overall cholesterol content in thebody. Omega-6 (n-6) polyunsaturated fatty acids (PUFA) in High LinoleicSunflower Oil (e.g., arachidonic acid (AA)) and omega-3 (n-3) PUFA(e.g., eicosapentaenoic acid (EPA)) are precursors to potent lipidmediator signaling molecules, termed “eicosanoids,” which have importantroles in the regulation of inflammation.

The composition in embodiments is engineered to have an optimalcombination of omega-3 and omega-6 fatty acids which are types ofessential fatty acids that could not be prepared on our own, which haveto obtain them from diet. Both are polyunsaturated fatty acids thatdiffer from each other in their chemical structure. There are twocritical omega-3 fatty acids, (EPA and DHA), that the patients require.Furthermore, vegetarian sources, which the present composition utilizes,such as chia seeds and flax seeds contain a precursor omega-3(alpha-linolenic acid called ALA) that the body must convert to EPA andDHA. EPA and DHA are the building blocks for hormones that controlimmune function, blood clotting, and cell growth as well as componentsof cell membranes.

In contrast, omega-6 foods containing these fatty acids are numerous inmodern diets. They are found in seeds and nuts, and the oils areextracted from them. The body also constructs hormones from omega 6fatty acids. In general, hormones derived from the two classes ofessential fatty acids have opposite effects. Those from omega-6 fattyacids tend to increase inflammation (an important component of theimmune response), blood clotting, and cell proliferation, while thosefrom omega-3 fatty acids decrease those functions. Both families ofhormones must be in balance to maintain optimum health, so there aresome omega-6 benefits. Many nutrition experts believe that before werelied so heavily on processed foods, humans consumed omega-3 andomega-6 fatty acids in roughly equal amounts. The imbalance betweenomega-3 and omega-6 fatty acids may also contribute to obesity,depression, dyslexia, hyperactivity and even a tendency toward violence.Bringing the fats into proper proportion may actually relieve thoseconditions. The composition of the present invention has a unique 3:1and 4:1 ratio of omega 6:omega 3 ratio, which facilitates balance ofthese fatty acids and contributes to the anti-inflammatory effects ofthem.

The nutrition composition further comprises agave inulin is a highlysoluble dietary fiber (inulin-type fructan) that provides numeroushealth benefits. Inulin serves as a “fertilizer” to sustain beneficialbifidobacteria in the large intestine. Inulin is clinically proven to beeasy to digest and promotes the growth of good bacteria in the gut suchas bifidobacteria. In studies, fecal actinobacteria and bifidobacteriumwere enriched 3- and 4-fold after ingestion of agave inulin, a longchain fructo-oligosaccharide (FOS), and desulfovibrio were depleted 40%with agave inulin compared with the control. Agave inulin tended toreduce fecal 4-methyphenol and pH. Total dietary fiber from agave inulinhas been positively associated with fecal butyrate and tended to bepositively associated with Bifidobacterium and was negatively correlatedwith desulfovibrio abundance. Organic inulin could be used in everydaylife as a prebiotic and food supplement that stimulates the growth andactivity of good bacteria in the body.

The nutrition composition further comprising MCT (Medium-ChainTriglycerides) oil which is quickly and easily digested and provides arelatively large amount of energy to the patient. They are associated tostimulate the metabolism and have been identified as a potential weightloss aid. If MCT oil is consumed to increase weight gain, a substantialamount of protein would aid in weight gain. Medium-chain triglyceridesare easily absorbed by the gastrointestinal tract and converted intoenergy by the liver. They are often digested well even by those whocannot digest normal, long-chain fatty acids. MCT is comprised ofprimarily caprylic and capric fatty acids. MCT helps to treat diseasessuch cystic fibrosis, and fat malabsorption. It has also been used toadd calories to infant and certain other formulas. Unlike other fats,MCT oil benefits because it does not go through the lymphatic system, itis transported directly to the liver where it is metabolized so itreleases energy like a carbohydrate and creates keytones.

The nutrition composition comprising organic milled chia are a goodsource of omega-3 fatty acids, which could be used as whole or ground.The organic milled chia is good for intestinal function. There are twocritical omega-3 fatty acids, (EPA and DHA), that the body needs.Vegetarian sources, such as chia seeds and flax seeds contain aprecursor omega-3 (alpha-linolenic acid called ALA) that the body mustconvert to EPA and DHA. EPA and DHA are the building blocks for hormonesthat control immune function, blood clotting, and cell growth as well ascomponents of cell membranes. Chia seeds act as functional foods and maycontribute to a better adherence to the dietary treatment in controllinghypercholesterolemia. Chia seeds have an impact on the concentration oftotal cholesterol (C), LDL-C, HDL-C and lipoprotein. Significantdecrease in serum LDL cholesterol was accompanied by a decrease in theconcentration of small LDL particles. In addition, systolic anddiastolic blood pressure decreases significantly as well as total bodyweight and BMI.

The nutrition composition further comprises organic quinoa flour, whichitself comprises higher dietary fiber content than in other grains. Thisfiber helps improve intestinal functions. In addition, two flavonoidsthat have been particularly well studied are quercetin and kaempferol,which are found in large amounts in quinoa. In fact, the quercetincontent of quinoa is even higher than typical high-quercetin foods likecranberries. These molecules have anti-inflammatory, anti-viral,anti-cancer and anti-depressant effects. Quercetin, a polyphenoliccompound and a major bioflavonoid in the human diet, hasanti-inflammatory properties and enhances energy expenditure. Naturallyoccurring flavonoids inhibit three reverse transcriptases. Quinoa isalso gluten-free making it an optimal choice for patients with celiac orgluten intolerances. By using quinoa instead of typical gluten-freeingredients like refined tapioca, potato, corn and rice flour,dramatically increases the nutrient and antioxidant value of the diet.Henceforth, the composition according to the present invention isgluten-free.

The nutrition composition further comprises organic rosemary extractwhich has been shown to boost memory, improve mood, reduce inflammation,relieve pain, protect the immune system, stimulate circulation, detoxifythe body, protect the body from bacterial infections, prevent prematureaging, and heal skin conditions; digestion problems, includingheartburn, intestinal gas (flatulence), liver and gallbladder complaintsand loss of appetite. The chemical in rosemary primarily responsible forantioxidation properties is carnosol, a phenolic diterpene also found inmountain desert sage. In addition to being a rich antioxidant, carnosolis also known for its anti-cancer and anti-inflammatory properties.According to a recent article published in the journal Cancer Letters,“Carnosol has been evaluated for anti-cancer property in prostate,breast, skin, leukemia, and colon cancer with promising results”. It hasalso been discovered that carnosol targets cells to reduce inflammationand can also balance androgen and estrogen in the body, reduce cancerrisks, increase nerve growth factor healing nerve tissue, and may have aselective toxicity towards cancer cells versus non-tumorigenic cells.

The nutrition composition comprising organic sunflower lecithin is goodfor heart health. It helps to prevent and reverse damage from coronarydisease. Lecithin is essentially an emulsifier of fat which could beused by the body to discard the excess fat from the bloodstream. Theseexcess fats include cholesterol and triglycerides meaning that it willhelp you to reduce and control the levels of cholesterol. Highconcentration of linoleic acid present in the sunflower lecithin helpsto perform the above process. In addition, olive oil has similar levelsof linoleic acid. Phospholipids also plays a vital essential role forliver health and prevents excessive accumulation of fat.

Further, another advantage of using sunflower lecithin is the extractionprocess. Sunflower lecithin gets extracted without the need forpotentially damaging chemical solvents such as acetone and hexane.Sunflower lecithin is produced through a cold press system, as likederiving oil from olives and similar products. Sunflower lecithin isabundant with essential choline and fatty acids, such asphosphatidylinositol.

The nutrition composition comprising organic vanilla flavor whichsoothes inflammation throughout the body. This is particularly effectivefor inflammation of the liver, which occurs due to numerous reasons,especially for immunocompromised individuals. Vanillin could help easearthritis, gout and other inflammatory conditions. Vanilla extract hasbeen evaluated for hepatoprotective activity against paracetamol-inducedliver damage in rats. The researchers orally administered an ethanolicextract of Vanilla planifolia or a control reference solution toexperimental animals with hepatotoxicity induced by paracetamol. It wasobserved that the plant extract was able to protect the liver againstthe injury induced by paracetamol in rats. This was proven by thetremendous reduction in serum enzymes alanine aminotransferase (ALT),aspartate aminotransferase (AST), alkaline phosphatase (ALP) andbilirubin. The ethanolic extract of Vanilla planifolia hashepatoprotective activity against paracetamol-induced hepatotoxicity inrats. Vanilla extract components were studied for the potential use asantioxidants for food preservation and as nutraceuticals in healthsupplements. The extract and pure standard compounds were screened toascertain their antioxidant properties using β-carotene-linoleate anddiphenyl picryl hydrazyl (DPPH) in vitro model systems. Interestingly,the study observed and supported the potential use of vanilla beanextracts as antioxidants.

The nutrition composition further comprises potassium citrate, which isan essential nutrient for homeostasis in the body. It works alongsidesodium to maintain normal blood pressure. Potassium is known as anelectrolyte, helps to maintain a healthy fluid balance in the body. Italso helps to transmit electrical pulses to allow proper nerve andmuscle function. Potassium citrate is specifically used to help maintaineffective body pH.

The nutrition composition further comprises a blend of phytochemicalextracts from fruits, vegetables, herbs, and spices has been reported todecrease reactive oxygen species (ROS), increase cellular oxygenconsumption in blood and mitochondria, decrease extracellular H₂O₂, andreduce TNFα-induced inflammatory response in humans. Phytochemicals arethe active ingredients that promote whole body health. The extracts donot contain any source ingredients such as, protein, fat, orcarbohydrates. The blend may include extracts of green tea and greencoffee but does not contain any caffeine. Blend of phytochemicalextracts from fruits, vegetables, herbs, and spices represents thelatest evolution in the fight against potentially-damaging freeradicals. The biological effects of a natural supplement on the changesof oxidative and nitrosative stress markers, as well as cellularmetabolic activity, have been clinically observed in the human body. Theblend of phytochemical extract has been reported to decrease ROS,increase cellular oxygen consumption in blood and mitochondria, decreaseextracellular H₂O₂, and reduce TNFα-induced inflammatory response inhumans. Administration of blend of phytochemical extract resulted instatistically significant long-term inhibition of mitochondrial andcellular ROS generation by as much as 17% as well as 3.5-timesinhibition in extracellular NADPH system-dependent generation of 02, andnearly complete inhibition of extracellular H₂O₂ formation. This wasreflected in more than two times inhibition of ex vivo cellularinflammatory response and also increases in bioavailable NOconcentration. Further, there was measured synergetic, biologicaleffects of a natural supplement on changes in OSM and cellular metabolicactivity. The unique design and activity of the plant-based naturalsupplement, in combination with the newly developed and extendedVitality test, demonstrates the potential of using dietary supplementsto modulate OSM and also opens the door to future research into the useof natural supplements for supporting optimal health.

According to the present invention, the biological active compounds andTotal Antioxidant Capacity Assay (TAC) for blend of phytochemicalextract per serving size of 100 mg is shown in below Table 3.

TABLE 3 Units Result Phytochemical compound Glucosinolates mg 0.1Quercetin mg 10.8 Lycopene μg 43 Chlorogenic acids mg 6.7 Vitamin C mg1.2 Catechins mg 10.3 Allicin μg 10 Alliin μg 20 Anthocyanins mg 0.5Vitamin E μg 13.4 Beta-carotene μg 36.4 Folate μg 1.2 Vitamin K μg 3.1Calcium mg 0.77 Magnesium mg 0.53 Potassium mg 4.3 Activity againstindividual radicals Activity against peroxyl radicals μmol TE 1070Activity against hydroxyl radicals μmol TE 1511 Activity againstperoxynitrite μmol TE 110 Activity against superoxide anion μmol TE 1337Activity against singlet oxygen μmol TE 417 Total activity μmol TE 4445(Source: Phytochemical Composition and Antioxidant Capacity of ThreeMalian Medicinal Plant Parts François Muanda, 1 Donatien Koné, 1 AmadouDicko, 1, *Rachid Soulimani, 2 and Chafique Younoshttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4256589)

The nutrition composition further comprises magnesium citrate toincrease fluid in the small intestine to prevent constipation. Magnesiumactivates over 300 enzyme reactions in the body, translating tothousands of biochemical reactions on a constant basis daily. Magnesiumis crucial to nerve transmission, muscle contraction, blood coagulation,energy production, nutrient metabolism, and bone and cell formation.

The nutrition composition further comprises potassium chloride whichbenefits include relief from stroke, high blood pressure, heart andkidney disorders, and anxiety and stress. It helps in enhancing musclestrength, metabolism, water balance, electrolytic functions, and nervoussystem. Chloride works with other electrolytes, such as sodium andpotassium, to help balance acids and bases in the body. It also helps tomove fluid in and out of the cells, which is also essential forpreventing dehydration.

Referring now to FIG. 3, a method 300 for preparing the nutritionalcomposition is illustrated. In an embodiment, the method comprises,protein slurry is formed by adding and mixing hydrolyzed pea protein towater for ten minutes, at step 302. At step 304, a protein-fat slurry isformed by mixing fat to the protein slurry for five minutes. At step306, all dry ingredients are added to the protein-fat slurry and mixedfor five minutes. At step 308, agave syrup is added to the mixture andmixed for ten minutes. At step 310, the composition is asepticallyproduced through a microthermics processor.

The nutritional composition further needs to be heated to a prescribedtemperature for a prescribed time period. The specific temperatures andtimes depend on the food involved. UHT, or Ultra High Temperaturetreatment takes place in optimized heat exchangers before packaging.This process minimizes heat penetration problems and allows very shortheating and cooling times, at the same time minimizing unwanted changesin the taste and nutritional properties of the composition.

The aseptic package has been sterilized prior to filling with UHT (UltraHigh Temperature) treated food, resulting in a product which is shelfstable for over 6 months. The Aseptic packaging method passes flat,unformed packaging material through a heated hydrogen peroxide bath. Ahydrogen peroxide concentration of 30% is heated at 70° C. for sixseconds. Hydrogen peroxide is then eliminated from the packagingmaterial using pressure rollers or hot air.

The environment where food is handled and sealed is free of potentiallycontaminating bacteria. Further, the filling and sealing machinery aremaintained sterile before packaging and during the production process.This could be achieved using hot air and steam or by combining heattreatment with hydrogen peroxide chemical sterilization.

Advantageously, the present invention is entirely plant-based and freeof the top eight allergens such as milk, wheat, soybeans, eggs, peanuts,tree nuts, fish and shellfish, corn, and is non-GMO (free ofnon-genetically modified organisms). In addition, it contains organicingredients, optimal fatty acid ratios, oxidation fighting ingredients,anti-inflammatory properties and beneficial fiber. Alternativeapproaches to the problem include formation of a blended food product.The composition is made with 100% pea protein hydrolysates for optimaldigestion.

Although a single embodiment of the invention has been described in theabove detailed description, it will be understood that the invention isnot limited to the embodiment developed herein, but is capable ofnumerous rearrangements, modifications, substitutions of parts andelements without departing from the spirit and scope of the invention.

The foregoing description comprises illustrative embodiments of thepresent invention. Having thus described exemplary embodiments of thepresent invention, it should be noted by those skilled in the art thatthe within disclosures are exemplary only, and that various otheralternatives, adaptations, and modifications may be made within thescope of the present invention. Merely listing or numbering the steps ofa method in a certain order does not constitute any limitation on theorder of the steps of that method. Many modifications and otherembodiments of the invention will come to mind to one skilled in the artto which this invention pertains having the benefit of the teachingspresented in the foregoing descriptions. Although specific terms may beemployed herein, they are used only in generic and descriptive sense andnot for purposes of limitation. Accordingly, the present invention isnot limited to the specific embodiments illustrated herein.

What is claimed is:
 1. A nutrient composition, comprising: at least oneprotein source comprising pea protein hydrolysate; one or morephytochemical extracts; one or more fatty acids; one or more organicingredients; and one or more prebiotic fibers.
 2. The composition ofclaim 1, wherein the at least one protein source constitutes 2.25 wt %to 6.5 wt % of the total composition, and the at least one protein is100 wt % pea protein hydrolysate based on total protein of the mixture.3. The composition of claim 1, wherein the phytochemical extracts is ablend of fruits, vegetables, herbs and spices.
 4. The composition ofclaim 1, wherein the phytochemical extracts comprises rosemary extract,blend of phytochemical extracts from fruits, vegetables, herbs, andspices, potassium citrate, magnesium citrate and potassium chloride. 5.The composition of claim 4, wherein the blend of phytochemical extractsfrom fruits, vegetables, herbs, and spices comprises one or moreconcentrates of broccoli sprouts, camu camu, tomato, acai, turmeric,garlic, basil, oregano, cinnamon, elderberry, chokeberry, raspberry,spinach, kale, brussels sprouts, extracts of green arabica coffee bean,green tea, onion, apple, acerola, Japanese pagoda tree, blackcurrant,blueberry, and bilberry.
 6. The composition of claim 4, comprising: (a)rosemary extract constitutes 0.03 wt % to 0.05 wt % of the totalcomposition, (b) blend of phytochemical extracts from fruits,vegetables, herbs, and spices constitutes 0.03 wt % to 0.04 wt % of thetotal composition, (c) potassium citrate constitutes 0.021 wt % of thetotal composition, (d) magnesium citrate constitutes 0.01 wt % of thetotal composition, and (e) potassium chloride constitutes 0.07 wt % ofthe total composition.
 7. The composition of claim 1, wherein the fattyacids comprises organic medium chain triglycerides and a balanced blendof omega-6 and omega-3 fatty acids.
 8. The composition of claim 7,wherein the medium chain triglycerides constitutes 2.3 wt % to 2.8 wt %of the total composition.
 9. The composition of claim 1, wherein thefatty acids further comprises organic sunflower lecithin, organic flaxseed oil, and organic high linoleic sunflower oil.
 10. The compositionof claim 9, comprising: (a) organic sunflower lecithin constitutes 0.1wt % of the total composition, and (b) organic flax seed oil constitutes1.1 wt % to 1.5 wt % of the total composition. (c) organic high linoleicsunflower oil constitutes 2.5 wt % to 3.5 wt % of the total composition.11. The composition of claim 1, wherein the organic ingredientscomprises vanilla plant extract.
 12. The composition of claim 1, furtheroptionally comprises one or more vitamin and mineral blend, purifiedwater and sea salt.
 13. The composition of claim 12, wherein the vitaminand mineral blend is selected from a group of dicalcium phosphate,potassium chloride, magnesium chloride, calcium carbonate, cholinebitartrate, sodium ascorbate, trisodium citrate, potassium citrate,L-cysteine, taurine, L-carnitine, inositol, L-tryptophan,DL-alpha-tocopheryl acetate, niacinamide, zinc oxide, ferricorthophosphate, calcium pantothenate, pyridoxine hydrochloride, coppersulfate, magnesium sulfate, riboflavin, thiamine hydrochloride, vitaminA palmitate, beta carotene, folic acid, biotin, chromium picolinate,phytonadione, sodium molybdate, sodium selenite, potassium iodide,vitamin D2 and vitamin B12.
 14. The composition of claim 12, comprising:(a) vitamin and mineral blend constitutes 0.8 wt % to 1.25 wt % of thetotal composition, (b) sea salt constitutes 0.03 wt % of the totalcomposition, and (c) purified water constitutes 68 wt % to 69.5 wt % ofthe total composition.
 15. The composition of claim 1, wherein theprebiotic fiber comprises organic agave inulin.
 16. The composition ofclaim 15, wherein the organic agave inulin constitutes 1 wt % to 1.2 wt% of the total composition.
 17. The composition of claim 1, furtheroptionally comprises organic brown rice syrup solids, organic agavesyrup organic quinoa flour, organic vanilla flavor and organic milledchia.
 18. The composition of claim 17, comprising: (a) organic brownrice syrup solid constitutes 6.5 wt % to 12 wt % of the totalcomposition, (b) organic agave syrup constitutes 2.25 wt % to 6.5 wt %of the total composition, (c) quinoa flour constitutes 0.02 wt % of thetotal composition, (d) vanilla flavor constitutes 1.1 wt % of the totalcomposition, and (e) milled chia constitutes 0.01 wt % of the totalcomposition.
 19. A method of using the nutrition composition of claim 1,said method comprising: administering the said nutrition compositionenterally or orally to the user, providing substantially one or morecombination of nutritional components, thereby fulfilling energyrequirements of said user without interfering with fluid absorption orcausing gastrointestinal disturbances.
 20. A method of making thenutrition composition, comprising the steps of: (a) forming a peaprotein slurry by mixing hydrolyzed pea protein to water for tenminutes; (b) forming a protein-fat slurry by mixing fat to the peaprotein slurry for five minutes; (c) mixing dry ingredients to theprotein-fat slurry for five minutes; (d) mixing agave syrup to a mixtureof step (c) for ten minutes; and (e) producing the compositionaseptically through a microthermic processor.